UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023029 |
|---|---|
| Receipt number | R000026539 |
| Scientific Title | Examination of the care prevention intervention method that increased a new comprehensive index for sarcopenia assessment |
| Date of disclosure of the study information | 2016/07/05 |
| Last modified on | 2016/07/05 17:00:05 |
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Basic information
Public title
Examination of the care prevention intervention method that increased a new comprehensive index for sarcopenia assessment
Acronym
ADL intervention study
Scientific Title
Examination of the care prevention intervention method that increased a new comprehensive index for sarcopenia assessment
Scientific Title:Acronym
ADL intervention study
Region
| Japan |
Condition
Condition
Local elderly people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For elderly people resident in an area, we conduct ADL movement instruction and perform the effect inspection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee VAS, JKOM, 5m walking speed, grip, patellar inferior mobility, Knee joint flexure excursion, Knee joint extension excursion, Ely' s test, muscular strength (knee extension, hip joint extension, hip joint abduction), SF-8, body composition.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
intervention
1 draw-in gait
2 Hip joint dominant ADL
3 Japanese sitting
Three months enforcement.
We record the number of times.
Interventions/Control_2
control
1 SLR ex, Ten times of 3 set
2 Knee automatic flexural excursion
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly people resident in an area
Key exclusion criteria
1 Dementia
2 Painful bone and joint disease
3 Cerebrovascular person with a disability
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Ota |
Organization
Department of Rehabilitation and Care, Seijoh, University.
Division name
Physical therapy
Zip code
Address
2-172 Fukinodai, Tokai, Aichi, 476-8588, Japan.
TEL
052-601-6245
ohko-h@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ohko |
Organization
Department of Rehabilitation and Care, Seijoh, University.
Division name
Physical therapy
Zip code
Address
2-172 Fukinodai, Tokai, Aichi, 476-8588, Japan.
TEL
052-601-6245
Homepage URL
ohko-h@seijoh-u.ac.jp
Sponsor or person
Institute
Department of Rehabilitation and Care, Seijoh, University.
Institute
Department
Personal name
Funding Source
Organization
Department of Rehabilitation and Care, Seijoh, University.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 05 | Day |
Last modified on
| 2016 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026539
